High intensity interval training for patients with congenital heart defects

High Intensity Interval Training in Patients With a Right Ventricle to Pulmonary Artery Conduit

This study is testing if a 12-week home workout program can help young people with certain heart defects exercise better and feel stronger.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 12 Years to 45 Years
• Sex: All
• Sponsor: Erasmus Medical Center (Academic / other)
• Locations: 2 sites (Nijmegen, Gelderland and 1 other locations)
• Trial ID: NCT06771687 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine if a 12-week home-based high intensity interval training program can enhance exercise capacity in individuals aged 12 to 45 with congenital heart defects requiring a right ventricle to pulmonary artery conduit. Participants will be divided into an intervention group, which will undergo the exercise program, and a control group, which will receive the intervention after an initial control period. The study also seeks to identify factors that may predict the effectiveness of the exercise training on improving exercise capacity. The target conditions include truncus arteriosus, pulmonary atresia with a ventricular septal defect, and severe tetralogy of Fallot.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 12 to 45 with congenital heart defects requiring a right ventricle to pulmonary artery conduit.

Not a fit: Patients with ventricular arrhythmias, severe heart dysfunction, or elite athletes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve the exercise capacity and overall quality of life for patients with specific congenital heart defects.

How similar studies have performed: Other studies have shown positive outcomes with exercise interventions in similar patient populations, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Congenital absence of an unobstructed connection between the right ventricle and pulmonary artery, requiring surgical implantation of a right ventricle to pulmonary artery conduit, including patients with:

   1. Truncus arteriosus
   2. Pulmonary atresia with ventricular septum defect
   3. Severe tetralogy of Fallot
   4. Other forms of pulmonary atresia with biventricular correction
2. Age 12 to 45 years.
3. Current follow-up in Academic Center for Congenital Heart Disease (ACAHA; Erasmus MC Rotterdam and Radboudumc Nijmegen).
4. Signed informed consent.

Exclusion Criteria:

1. Ventricular arrhythmias and/or channelopathy.
2. Implantable cardioverter defibrillator implantation due to inherited arrhythmia syndromes.
3. Left ventricular ejection fraction and/or right ventricular ejection fraction less than 30 percent.
4. Elite athletes (i.e. national team, Olympians, professional athletes, exercising equal to or more than 10 h/week, according to definition in 2020 European Society of Cardiology Guidelines for Sports Cardiology and Exercise in Patients with Cardiovascular Disease).
5. Cardiovascular lesions requiring intervention (according to international guidelines).
6. Cardiovascular intervention (surgery or catheterization) less than 6 months ago.
7. Cardiovascular medication changes less than 3 months ago.
8. Hospitalization for treatment of cardiovascular events less than 6 months ago.
9. Comorbidities or developmental delay impeding exercise training (e.g. neuromuscular disease, symptomatic myocardial ischemia, syndromic diagnoses such as trisomy 21).
10. Inability to provide informed consent.

Where this trial is running

Nijmegen, Gelderland and 1 other locations

• Radboudumc — Nijmegen, Gelderland, Netherlands (Not_yet_recruiting)
• ErasmusMC — Rotterdam, South Holland, Netherlands (Recruiting)

Study contacts

• Principal investigator: Beatrijs Bartelds, MD, PhD — Erasmus Medical Center
• Study coordinator: Anouk S Moerdijk, MD

Conditions Congenital Heart Disease; Truncus Arteriosus; Pulmonary Atresia; Tetralogy of Fallot; Heart Defects, Congenital; Truncus Arteriosus, Persistent; Physical Conditioning, Human; High-Intensity Interval Training